Appeals Court Urged to Overturn Dismissal of Zostavax Shingles Lawsuits

Plaintiffs seek the reinstatement of about 1,200 Zostavax lawsuits over shingles injuries, saying their claims were dismissed for not having evidence that doesn’t exist.

Hundreds of plaintiffs are joining together to ask a federal appeals court to reinstate their Zostavax shingles lawsuits, after the trial judge dismissed the claims when they were unable to comply with a pretrial order requiring they produce certain evidence that was non-existent and “simply impossible” to provide.

Each of the lawsuits raised similar allegations against Merck, indicating that the shingles vaccine caused them to develop severe versions of the condition the injection was designed to prevent.

Before allowing the cases to proceed the U.S. District Judge presiding over the litigation required each plaintiff to provide PCR evidence establishing that their shingles was linked to the live strain of the virus contained in the vaccine, even though such testing was never done and is incapable of being created after-the-fact.

Lawsuits Allege Zostavax Vaccine Caused Shingles Outbreaks

Merck introduced Zostavax in 2006, as the first vaccine approved in the United States for prevention of shingles, which involved a single-dose injection that contained a live virus that was intended to prevent development of the painful condition. However, lawsuits allege the vaccine was defectively designed and poses an unreasonable risk, since the live virus was not sufficiently weakened, causing some users to experience more severe and persistent shingles outbreaks, a well as a variety of neurological problems, autoimmune diseases, vision loss and hearing damage.

Given similar questions of fact and law raised in complaints filed throughout the federal court system, all Zostavax lawsuits have been centralized before U.S. District Judge Harry Bartle in the U.S. District Court for the Eastern District of Pennsylvania, as part of a federal multidistrict litigation (MDL), where several groups of “bellwether” cases were prepared for trial, involving different categories of injuries.

About 1,200 cases were represented by a “Group A” bellwether pool, involving plaintiffs who allege they developed shingles or a shingles related injuries after receiving the injection. However, following pretrial discovery, Judge Bartle dismissed all Group A cases involving shingles lawsuits, after the Court excluded expert witness testimony linking the live virus vaccine to the reactivation of the shingles virus that lay dormant in recipients.

As a result, the only cases remaining active in the MDL are those involving injuries that are part of a “Group B” bellwether pool, for plaintiffs who developed other autoimmune disorders, such as postherpetic neuralgia, acute disseminated encephalopmyelitis (ADEM), paralysis, traverse myelitis, meningitis, hemorrhagic strokes and other injuries, or a “Group C” pool, for individuals who developed hearing loss from Zostavax.

Zostavax Shingles Injury Lawsuits Dismissal Appealed

On May 10, plaintiffs filed a petition (PDF) with the U.S. Court of Appeals for the Third Circuit, seeking to overturn Judge Bartle’s dismissal of the Zostavax shingles lawsuits, and reinstate approximately 1,200 cases.

Plaintiffs argue that Judge Bartle dismissed their claims because they could not produce “a type of DNA evidence that simply does not exist and never existed,” which unlawfully deprived plaintiffs of the opportunity to have their evidence weighed before a jury.

During pretrial proceedings, Merck called for plaintiffs to be required to take a type of DNA test, known as polymerase chain reaction (PCR) testing, which they said would be the only 100% conclusive evidence that Zostavax caused their shingles outbreaks.

Over plaintiffs’ objections, Judge Bartle agreed to require the testing, and issued a “Lone Pine” case management order, which required each plaintiff to produce this evidence before their claim could proceed. However, plaintiffs say the PCR test can only be done when a shingles rash is visible, so it cannot be done on demand. In addition, the tests were never the standard of care for shingles, so none of the plaintiffs had the test data available to provide as evidence that their shingles was caused by Zostavax.

Finally, plaintiffs noted in the appeal brief that the PCR tests can’t conclusively determine whether Zostavax caused the shingles outbreaks as the court claims it can, which defendants’ experts conceded during early Zostavax bellwether trials.

“The district court’s order improperly assumes that the only way to conclusively (meaning with 100% assurance) determine whether the Zostavax vaccine caused a specific outbreak of shingles is to perform PCR testing on DNA obtained from an active shingles lesion,” the plaintiffs’ brief states. “Not only is this assumption inaccurate, as could have been explained by plaintiffs’ experts had the district court given them the opportunity to do so, but for the plaintiffs to prevail, they do not have the burden to come forth with conclusive (100%) evidentiary support of specific causation; rather, the burden is preponderance of the evidence.”

Plaintiffs are asking the appeals court to reinstate the claims, allowing the Zostavax shingles lawsuits to rejoin the rest of the consolidated litigation and its move forward with a series of early test trial cases to help gauge how juries are likely to respond to certain evidence and testimony that may be repeated throughout the litigation.